Substance Use Disorder (SUD)NCT05632185
Equine-assisted Therapy Effectiveness in Improving Emotion Regulation of Patients Suffering From Substance Use Disorder
A study testing Equine-assisted Therapy in people with Substance Use Disorder (SUD), run by Suez Canal University at 1 site in Egypt.
Trial summary
Substance Use Disorder (SUD) is a term replacing the diagnoses of abuse and dependence adopted in DSM-4 and DSM-5 . It is an overwhelming public health problem throughout the world, with increasing trends throughout the last few decades. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Equine-assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2022to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult diagnosed with substance use disorder, hospitalized for at least one month in the study hospital, and physically able to deal with horses
Who cannot join
- other physical or psychological ailments preventing them from active participation in the intervention
Trial locations and contacts
1 site in 1 country.
Nagwa Souilm, Doctor contact
Egypt1 site, 1 recruiting
- Recruiting
Behman hospital, Helwan, Cairo, Egypt
Cairo
Nagwa Souilm, Doctor, nagwamohamed@rocketmail.com
About this study
Official title: Equine-assisted Therapy Effectiveness in Improving Emotion Regulation, Self-efficacy, and Perceived Self-esteem of Patients Suffering From Substance Use Disorder
Substance Use Disorder (SUD) is a term replacing the diagnoses of abuse and dependence adopted in DSM-4 and DSM-5 . It is an overwhelming public health problem throughout the world, with increasing trends throughout the last few decades. This study aims to assess the effectiveness of quine-assisted addiction therapy in improving emotion regulation, self-efficacy, and perceived self-esteem among patients suffering from substance use disorders. This open-label randomized controlled trial study will be conducted at Behman hospital, Helwan, Cairo, Egypt.
It will include all patients suffering substance use disorder randomized into two equal groups: one group will receive Equine assisted intervention, and a control group to receive the regular care used in the setting. A self-administered questionnaire with tools for emotion regulation questionnaire, General Self-efficacy (GSE) scale, and Self- Esteem will be used to collect data.
Read the detailed description
Research design: A randomized controlled trial design will be utilized in this study.
Setting: The study will conduct Behman hospital, Helwan, Cairo, Egypt. It was founded in 1940 as the first private psychiatric hospital in Egypt. With a 210-bed capacity, the hospital is considered as one of the biggest medical centers in Helwan, Egypt. The hospital is the pioneer of equine psychotherapy in Egypt.
Duration of the Study: The four phases of data collection are expected to take 6 months, from December 2022 to May 2023.
Subjects: The study population will consist of all Patients suffering from substance use disorder receiving their care at Behman hospital, during the time of the study. The inclusion criteria will be being adult diagnosed with substance use disorder, hospitalized for at least one month in the study hospital, and physically able to deal with horses. Those patients suffering from any other physical or psychological ailments preventing them from active participation in the intervention will exclude. The remaining patients will equally randomized, using simple random numbers computer program, into an intervention group to receive the equine assisted therapy and a control group to receive the regular care used in the setting.
Data collection tools: Data will be collected using a self-administered questionnaire with standardized tools for assessment of emotion regulation, General Self-Efficacy, and perceived self-esteem, in addition to a section for the demographic and disease characteristics developed by the researchers. This cover data about patient age, gender, current marital status, place of residence, educational level, current job status, income, as well as age at start and duration of substance of use etc.
The first tool emotion regulation questionnaire developed by Gross and John (2003). It will be used to assess how respondents tend to regulate their emotions positively through cognitive reappraisal, or negatively through expressive suppression. It consists of ten statements: 6 for cognitive reappraisal (such as "When I want to feel more positive emotion, I change the way I'm thinking about the situation"), and 4 for expressive suppression (4 statements such as "When I am feeling negative emotions, I make sure not to express them"). The responses are on a 7-point Likert-type scale ranging from "strongly disagree" to "strongly agree." The scores of each dimension are summed giving a maximum total score of 42 for the appraisal dimension and 28 for the suppression dimension. A higher score indicates more appraisal or more suppression. Scoring is kept continuous according to tool instructions. The tool demonstrated high validity and reliability in previous studies (Mauss et al., 2005; Ochsner and Gross, 2005).
The second tool will be the General Self-efficacy (GSE) scale developed by Schwarzer and Jerusalem (1995). It also has 10 statements on a 4-point Likert type scale ranging from "not at all true" (scored 1) to "exactly true" (scored 4). Examples of statements are: "It is easy for me to stick to my aims and accomplish my goals," and "I can solve most problems if I invest the necessary effort." A total score ranging from 10 to 40 is obtained simple summation of items' scores. A higher score denotes more GSE. The reliability of the tool as well as its concurrent and predictive validity were documented (Schwarzer and Jerusalem, 2010).
The third tool will be the self-esteem test developed by Sorensen (2006). The tool has 50 statements such as: "I often feel like I don't know what is expected of me," and "I am not vey aware of my feelings." The respondent is asked to check the statements he/she feels true for him/her. The number of items checked is calculated, ranging from zero to 50. A higher number indicates lower self-esteem. The tool was validated and showed good reliability (Martín-Albo et al., 2007).
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- Equine-assisted Therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine-assisted TherapyBehavioural
An equine therapy session typically consists of specific tasks and challenges to overcome, with the aid and guidance of horses. There is no riding involved and no specific skills are necessary to take part in these sessions
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | standard regular treatment modalities |
| Equine assisted intervention | Active comparator | patients will receive weekly equine-assisted therapy sessions over a period of 8 weeks in addition to their standard regular therapy Receives: Behavioral: Equine-assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
emotion regulation questionnaire
assess how respondents tend to regulate their emotions positively through cognitive reappraisal, or negatively through expressive suppression.
Measured: Six months
General Self-efficacy (GSE) scale
10 statements on a 4-point Likert type scale ranging from "not at all true" (scored 1) to "exactly true" (scored 4)
Measured: Six months
the self-esteem test
50 statements such as: "I often feel like I don't know what is expected of me," and "I am not vey aware of my feelings." The respondent is asked to check the statements he/she feels true for him/her.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start10 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group will receive Equine assisted intervention, and a control group to receive the regular care used in the setting
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nagwa Souilm, Doctor, Principal investigator, Bani-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632185
- Sponsor's protocol ID
- FMBSUREC/06112022
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equine-assisted Therapy Effectiveness in Improving Emotion Regulation, Self-efficacy, and Perceived Self-esteem of Patients Suffering From Substance Use Disorder
- ClinicalTrials.gov ID
- NCT05632185
- Acronym / sponsor ID
- FMBSUREC/06112022
- Conditions
- Substance Use Disorder (SUD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Substance Use Disorder (SUD) is a term replacing the diagnoses of abuse and dependence adopted in DSM-4 and DSM-5 . It is an overwhelming public health problem throughout the world, with increasing trends throughout the last few decades. This study aims to assess the effectiveness of quine-assisted addiction therapy in improving emotion regulation, self-efficacy, and perceived self-esteem among patients suffering from substance use disorders. This open-label randomized controlled trial study will be conducted at Behman hospital, Helwan, Cairo, Egypt.
It will include all patients suffering substance use disorder randomized into two equal groups: one group will receive Equine assisted intervention, and a control group to receive the regular care used in the setting. A self-administered questionnaire with tools for emotion regulation questionnaire, General Self-efficacy (GSE) scale, and Self- Esteem will be used to collect data.
Detailed description
Research design: A randomized controlled trial design will be utilized in this study.
Setting: The study will conduct Behman hospital, Helwan, Cairo, Egypt. It was founded in 1940 as the first private psychiatric hospital in Egypt. With a 210-bed capacity, the hospital is considered as one of the biggest medical centers in Helwan, Egypt. The hospital is the pioneer of equine psychotherapy in Egypt.
Duration of the Study: The four phases of data collection are expected to take 6 months, from December 2022 to May 2023.
Subjects: The study population will consist of all Patients suffering from substance use disorder receiving their care at Behman hospital, during the time of the study. The inclusion criteria will be being adult diagnosed with substance use disorder, hospitalized for at least one month in the study hospital, and physically able to deal with horses. Those patients suffering from any other physical or psychological ailments preventing them from active participation in the intervention will exclude. The remaining patients will equally randomized, using simple random numbers computer program, into an intervention group to receive the equine assisted therapy and a control group to receive the regular care used in the setting.
Data collection tools: Data will be collected using a self-administered questionnaire with standardized tools for assessment of emotion regulation, General Self-Efficacy, and perceived self-esteem, in addition to a section for the demographic and disease characteristics developed by the researchers. This cover data about patient age, gender, current marital status, place of residence, educational level, current job status, income, as well as age at start and duration of substance of use etc.
The first tool emotion regulation questionnaire developed by Gross and John (2003). It will be used to assess how respondents tend to regulate their emotions positively through cognitive reappraisal, or negatively through expressive suppression. It consists of ten statements: 6 for cognitive reappraisal (such as "When I want to feel more positive emotion, I change the way I'm thinking about the situation"), and 4 for expressive suppression (4 statements such as "When I am feeling negative emotions, I make sure not to express them"). The responses are on a 7-point Likert-type scale ranging from "strongly disagree" to "strongly agree." The scores of each dimension are summed giving a maximum total score of 42 for the appraisal dimension and 28 for the suppression dimension. A higher score indicates more appraisal or more suppression. Scoring is kept continuous according to tool instructions. The tool demonstrated high validity and reliability in previous studies (Mauss et al., 2005; Ochsner and Gross, 2005).
The second tool will be the General Self-efficacy (GSE) scale developed by Schwarzer and Jerusalem (1995). It also has 10 statements on a 4-point Likert type scale ranging from "not at all true" (scored 1) to "exactly true" (scored 4). Examples of statements are: "It is easy for me to stick to my aims and accomplish my goals," and "I can solve most problems if I invest the necessary effort." A total score ranging from 10 to 40 is obtained simple summation of items' scores. A higher score denotes more GSE. The reliability of the tool as well as its concurrent and predictive validity were documented (Schwarzer and Jerusalem, 2010).
The third tool will be the self-esteem test developed by Sorensen (2006). The tool has 50 statements such as: "I often feel like I don't know what is expected of me," and "I am not vey aware of my feelings." The respondent is asked to check the statements he/she feels true for him/her. The number of items checked is calculated, ranging from zero to 50. A higher number indicates lower self-esteem. The tool was validated and showed good reliability (Martín-Albo et al., 2007).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- one group will receive Equine assisted intervention, and a control group to receive the regular care used in the setting
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –standard regular treatment modalities |
| Equine assisted intervention | Active comparator | Behavioral: Equine-assisted Therapypatients will receive weekly equine-assisted therapy sessions over a period of 8 weeks in addition to their standard regular therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult diagnosed with substance use disorder, hospitalized for at least one month in the study hospital, and physically able to deal with horses
Key exclusion criteria (1 listed)
- other physical or psychological ailments preventing them from active participation in the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equine-assisted TherapyAn equine therapy session typically consists of specific tasks and challenges to overcome, with the aid and guidance of horses. There is no riding involved and no specific skills are necessary to take part in these sessions | Behavioural | Equine assisted intervention |
Primary outcome
emotion regulation questionnaire
Time frame: Six months
assess how respondents tend to regulate their emotions positively through cognitive reappraisal, or negatively through expressive suppression.
General Self-efficacy (GSE) scale
Time frame: Six months
10 statements on a 4-point Likert type scale ranging from "not at all true" (scored 1) to "exactly true" (scored 4)
the self-esteem test
Time frame: Six months
50 statements such as: "I often feel like I don't know what is expected of me," and "I am not vey aware of my feelings." The respondent is asked to check the statements he/she feels true for him/her.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagwa Souilm, Doctor contact
Nagwa Souilm, Doctor principal investigator
Bani-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equine-assisted Therapy in people with Substance Use Disorder (SUD), run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nagwa Souilm, Doctor (nagwamohamed@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emotion regulation questionnaire (time frame: Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.